The present invention is directed to a packaging vial for a liquid product, in particular medicinal or cosmetic, for example eye lotion which is designed to be instilled into the eye of a person. The present invention is also directed to the manufacturing process of this vial.
For the purposes of this description and claims, by "liquid product" is meant a liquid or pasty substance, likely to conform to the shape of its container, and to be expelled therefrom in the form of a stream, which is continuous or composed of individual drops.
In certain therapeutic treatments, it is necessary to periodically dispense a dose of a liquid medicament contained in a vial, to inject or deposit it in a precise place of the organism of the patient.
Thus, for example, for treating glaucoma, the patient must instil regularly--in general once in the morning and once in the evening--a determined dose of eye lotion into each eye.
In many applications, it is important that the delivered dose has a well determined volume. The supply of a too small quantity may affect the effectiveness of the treatment. The supply of a too large quantity not only wastes product, but furthermore may cause side effects. This is how, to return to eye treatment, the excess volume of eye lotion (not absorbed by the surface of the eye) may pass, via the tear duct, into the mouth, then into the esophagus and stomach of the patient. Yet, the ingestion of certain eye lotions can sometimes present a danger, particularly if they contain beta-blocking agents.
It is thus important to be able to deliver the exact dose of the product required by the patient.
It is already common practice to package liquid medicaments in vials with flexible walls. In this case, the product dose is dispensed by pressing the wall, either manually, or by employing an appropriate apparatus.
This is how, for example, specification EP-A-0 437 953, describes an eye lotion instillation apparatus whose embodiment represented in FIGS. 1 through 4 includes a housing receiving a vial filled with eye lotion. The vial has the general shape of a bottle having a semi-rigid cylindrical body, with an elastically distortable wall, as well as a nozzle pierced with a product outlet orifice. The apparatus is shaped so that it can be applied against the eyeball and it is equipped with a moveable member, for example a rotating roller, capable of pushing the eyelid back to the cul-de-sac level during instillation. The housing is equipped with an articulated lever outfitted with a projection coming into contact with the wall of the vial body. The end of this lever is engaged with the roller, in an offset manner. To use the apparatus, the patient holds it in one hand, and after having correctly positioned it against the eyeball, presses with his fingers on the lever so as to simultaneously, push back the eyelid and expose the cul-de-sac (by rotation of the roller) and make a drop of the product come out (by distortion of the vial wall).
This type of device is not entirely satisfactory since the quantity of eye lotion expelled from the vial is not precise. It depends directly on the dimensions of the outlet orifice, as well as on the pressure exerted by the user on the housing. The result is thus linked to the strength and skill of the patient. This is a genuine problem since this type of apparatus is often intended for use by elderly people, not always acting with the skill required.
Another disadvantage of this type of device comes from the fact that after a certain dose of the product has been dispensed, the wall of the vial elastically takes back its initial shape, sucking therein a volume of air equal to that of the dose of the product that was dispensed. Thus, the vial progressively fills up with air, as the volume of the product diminishes. This mass of air, harmful for certain products, is a source of contamination that should be avoided.
In another embodiment of the vial, which is represented in FIG. 34 of the above mentioned specification EP-A-0 437 953, the valve for dosing and dispensing eye lotion is integrated into the vial. The latter includes a first rigid hollow body, containing the product, capable of telescopically sliding into a second hollow body, which is also rigid. The latter is firmly attached to a valve stem which is pierced with a central channel and bears a shoulder located inside the inner hollow body and capable of fitting into a cavity formed in the bottom wall thereof. The unit comprised of the two telescopic bodies and of the valve acts as a pump. By thrusting the inner body into the outer body, the shoulder is made to come out of the cavity, which allows the product to enter therein. First, the reverse movement, caused by a spring placed between the two hollow bodies, traps a certain volume of liquid in the cavity, and it then drives it therefrom under pressure. This volume is then expelled through the channel cut in the valve stem, coming out of the vial in the form of drops through a small valve provided at the end of the outer hollow body.
This vial, which is designed for use with a special instilling apparatus, also described in this specification, is in principle adapted to dispensing properly measured successive doses of the product, doses whose volume corresponds to that of the cavity.
Furthermore, the inner body is sealed by a cap which is capable of sliding therein like a piston in a cylinder, as the volume of the liquid diminishes, which compensates for this reduction in volume and prevents air from entering the vial.
This solution is not acceptable for the packaging of most cosmetic or pharmaceutical products because the piston/cylinder contacting walls, which define a sliding seal, enable the propagation of external bacteria toward the inside of the vial. The sliding seal is also a source of leakages.
Furthermore, the structure of such a vial, which requires a high number of parts, is not adapted to the manufacturing on a large or very large scale.
The main object of the present invention is to avoid these various disadvantages by proposing a vial of the type mentioned above, which, while allowing the delivery of successive doses of liquid product in the form of a well defined and exact volume, may be mass produced at a large, even very large scale, with a very low cost price, this in perfect conditions of hygiene, during the vial manufacturing process as well as when it is being filled, its later storage and its final use by the patient.
Another object of this invention is to plan for means of informing the user of the fact that the number of doses for which the vial is assigned has been reached, even which renders the vial unusable at this point.
Another object of this invention is to plan for means which accomplish the expulsion of the product in the form of a stream or drops according to a well defined space direction, and from a certain angle in relation to the general axis of the vial. This is particularly interesting for the installation of eye lotion since, in this case, the drops must preferably be accurately projected into the cul-de-sac located at the base and in an angle of the eye.
This invention is also directed to a vial manufacturing process which is especially economical and satisfactory regarding hygiene and quality of the finished product, this product being adapted to be mass produced at a large or even very large scale.
These various objects are fulfilled, according to this invention, thanks to the fact that the packaging vial includes a flexible casing attached to a rigid support, this casing comprising a pocket with thin and distortable walls, containing the product and free of air, as well as a tubular nozzle for delivering the product, to which is connected the pocket, and that the pump is a part of the vial, this pump including a fixed body inserted into the nozzle and a moveable actuating member which is located inside the casing, but which can be displaced from the outside of the latter, given the distortable character of its wall close to the actuating member.
Furthermore, according to a certain number of additional non-limiting characteristics:
the nozzle is sealed by an easily tearaway element, for example divisible; PA1 said rigid support includes a cartridge made out of plastic material, provided with a means for retaining the nozzle and the pocket centering members; PA1 the means for retaining the nozzle is a bracket set at a right angle in relation to the plane of said cartridge and pierced with an aperture in which the nozzle is ratchetably fixed and then locked; PA1 the centering members of the pocket consist of a pair of legs set at a right angle in relation to the plane of said cartridge, between which the pocket is made fit; PA1 at least one of said legs bears an informative mark in relation to the product or to the characteristics of the vial; PA1 the pocket has an elongated shape of which the major axis substantially extends the axis of the tubular nozzle, the bottom of this pocket, which is located at the opposite end of the nozzle, being closed by soldering; PA1 the vial is provided with means for counting the number of doses delivered, which are borne by the rigid support; PA1 the counting means include two free-rotating gears located near one another of which the first is designed to turn a fraction of a turn each time that a dose of the product is delivered and it is designed to turn the second gear a fraction of a turn, by using an actuating leg, each time it goes completely around; PA1 one of the teeth of the second gear is shaped in such a way that it prohibits movement to be continued after a complete turn of this second gear; PA1 the pump includes a variable volume chamber and is arranged so that the movement of said actuating member in one direction accomplishes sucking up of the product in the pocket into the chamber, while its movement in the other direction accomplishes a backward flow of a calibrated dose of the product therefrom, to the outside of the casing; PA1 the pump body is pierced with a channel which from the uphill side (towards the inside of the casing) comes out in said chamber and from the downhill side (towards the outside) comes out opposite the inner wall of the end portion of the nozzle, this wall applying itself intimately against the outer wall of the body and presenting an easily distortable zone, the pressure of the product during backward flow being sufficient to temporarily spread said easily distortable zone apart from the body of the pump and allow the product to be ejected therefrom; PA1 the easily distortable zone extends peripherally over a limited portion, while the rest of the periphery of the wall of the nozzle is relatively firm in this area, so that the ejection of the product takes place according to a determined space orientation; PA1 the easily distortable zone is obtained by the presence of a cavity cut in the wall of the nozzle; PA1 On the uphill side, the pump body shows a truncated cone-like free end, so that the ejection of the product takes place according to an acute angle in relation to the axis of the nozzle; PA1 the nozzle has a general shape of revolution, while the pump body also has at least one portion with the general shape of a revolution fitted into the nozzle, coaxially with the latter, this portion showing an annular shoulder providing its connection in axial direction with the wall of the nozzle; PA1 the actuating member of the pump is moveable in translation according to the axis of the nozzle and of the pump body, and has an annular base providing its connection in axial direction with the wall of the nozzle near the connecting zone of the latter with the pocket, while, in its portion separating the shoulder from the base, the wall of the nozzle forms an axially distortable bellow; PA1 the actuating member of the pump is moveable in translation according to an axis perpendicular to the axis common to the nozzle and to the portion of the pump body which has a shape of a revolution; PA1 the actuating member of the pump is situated inside the pocket, facing a zone of its wall which is coupled to the rest of the pocket wall by a bellows which is transversely distortable in relation to said common axis. PA1 the pump body shows a pan which is set at a right angle in relation to the portion fitted into the nozzle and which serves to guide the actuating member in translation; PA1 the actuating member has the general shape of a socket which shows a cylindrical part with a closed bottom forming a cylinder, while said part set at a right angle in relation to the pump body includes a tubular cylindrical sleeve forming a piston, which fits into this cylindrical portion; PA1 the inside of the sleeve and the inside of the cylindrical part define said variable volume chamber; PA1 the vial includes a spring accommodated in the pocket which stresses the actuating member in the direction of an extension of the bellows and of a reduction of the volume of said variable volume chamber; PA1 the easily tearaway sealing element is obtained by crushing the end portion of a tubular part made of relatively rigid material which is molded on the end of the nozzle, this element being separated from the rest of the part by a divisible zone; PA1 a) The flexible casing out of synthetic material, the latter having its bottom open on one hand and on the other hand a strengthening piece out of plastic material whose said rigid support is a constituent which can be easily separated therefrom are made through molding; PA1 b) the casing is coupled to said rigid support; PA1 c) the pump is introduced inside the pocket through the open bottom, and the fixed body is inserted therein into the nozzle; PA1 d) the end of the nozzle is sealed by soldering; PA1 e) the pocket is filled with the product; PA1 f) the bottom of the pocket is sealed by soldering; PA1 g) certain constituent elements of the strengthening piece are detached from said rigid support, said elements having been useful for the transport, guiding and placing of the pump. PA1 when the vial contains a rigid support provided with counting means, these means are accomplished through molding, at the same time as the rigid support; PA1 during step (c), the casing is pneumatically inflated so as to facilitate insertion of the pump body into the nozzle, the latter being in an expanded state, said operation being carded out by using the rigid part of the support as a sill for the inflating head; PA1 at the end of step (c), the behavior of the pump and-of the nozzle is tested by internally pressurizing the casing; PA1 after step (d), the casing--pump--strengthening piece group is temporarily packaged in a sealed film, then sterilized; PA1 steps (e) and (f) are carded out in a vacuum and in a sterile environment; PA1 the strengthening piece has the general shape of a rectangular parallelepiped delimited by two substantially rectangular cartridges set opposite one another, and of which one is a constituent of said rigid support, these cartridges being coupled two by two by their small sides, employing divisible fasteners, to frame-shaped elements, the whole unit forming a housing which can receive and retain the casing; PA1 one of the frame-shaped elements is adapted to support the outer side of the open bottom edge of the pocket, when internal pressure is applied thereon, during or at the end of step (c); PA1 a group of strengthening pieces juxtaposed and grouped together is simultaneously molded, so that the two cartridges delimiting the rectangular parallelepiped of a strengthening piece consist in its own rigid support for one of the two cartridges, and in the rigid support of an adjacent piece for the other cartridge;
The manufacturing process of a packaging vial such as that which has just been presented above, is remarkable in that it includes the following steps:
Furthermore, according to a certain number of additional advantageous but non-limiting characteristics of the process:
Other characteristics and advantages of this invention shall appear in the description which shall now be made with reference to the appended drawings.